MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-N180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined, however, there was the possibility that the reported phenomenon was attributed to the following.The cause of this event might be that the connecting part of the bending section was deformed.Since the direction in which the bending tube was deformed was not the direction in which the device could be bent, it was considered that the bending tube was bent by a strong external force.It could not be assumed that a strong external force was applied to the curved tube during the procedure, so it was presumed to be handled outside the procedure.Therefore, it was presumed that this event was caused by the handling of the user.Olympus stated that the appropriate handling and the inspection of the device in the instruction manual.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the service department of olympus (b)(4) (oekg), it was found that the rubber of the bending section of the subject device had been torn and the inner metal had been protruding.There was no report of patient injury associated with the event.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10475550
• Report Number: 8010047-2020-06035
• Device Sequence Number: 2990774
• Product Code: FDS
• UDI-Device Identifier: 04953170202261
• UDI-Public: 04953170202261
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GIF-N180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1